Ranitidine temporarily banned

The Directorate General of Drug Administration (DGDA) has temporarily banned the production of all Ranitidine-type of medicines manufactured with raw materials that were imported from the two Indian companies.

DGDA on Sunday sent a press release about the decision to different media houses of the country following a meeting between DGDA and representatives of Bangladesh Association of Pharmaceutical Industries (BAPI).

The meeting was presided over by DGDA director general major general Mahbubur Rahman.

Ranitidine tablets are mostly used to treat the acidity.

Ranitidine hydrochloride is used to manufacture the tablets. The two Indian companies—Saraca Laboratories Limited and Dr Reddy’s Laboratories—supply the raw material. Nitrosodimethylamine (NDMA) was found in the raw materials, which the US Food and Drug Administration (FDA) classified as risk for cancer.

Dr Reddy’s Laboratories stopped their supply of Ranitidine from 22 September. Multinational company GSK recalled the medicine from the market which used the raw material of Saraca Laboratories Limited.

On 19 September, European Directorate for the Quality of Medicines (EDQM) cancelled the certification of Saraca Laboratories Limited.

A number of Bangladeshi companies imported raw materials from these two Indian companies which were later sold in the market in different names.

DGDA said the pharamceutical company has to obtain a certificate from an internationally recognised organisation that testifies that NDMA is at a tolerable level in the imported ranitidine hydrochloride and submit this to the drug directorate.

DGDA will take measures after monitoring the actions of US, Europe, and Canada over the drug issue.